Pulmonary Disease, Chronic ObstructivePhase 4NCT02172508
Effect of Tiotropium Inhalation Capsules on Exercise Tolerance, Daily Activity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 3 Weeks of Pulmonary Rehabilitation
A Phase 4 study testing Tiotropium Inhalation Capsule in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium Inhalation Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Mar 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must sign an Informed Consent Form consistent with ICH-GCP guidelines prior to participation in the trial, which might include pre-study washout of their usual pulmonary medications and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with an FEV1 ≤ 65% of predicted normal and FEV1 ≤ 70% of FVC on visit 1 and 3.
- Patients must show TGV ≥ 120% of predicted normal
- Male or female patients ≥ 40 but ≤ 75 years old
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
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- Patients must be able to perform all study related tests including the exercise tests, acceptable pulmonary function tests and must be able to maintain records during the study period as required in the protocol.
- Patients must be able to inhale medication from the HandiHaler® and from a metered dose inhaler.
- Patients must be already eligible for participation in a pulmonary rehabilitation program as per the investigator's usual criteria.
Who cannot join
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinanalysis, if the abnormality defines a disease listed as an exclusion criterion.
- All patients with an serum glutamic-oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic-pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition.
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count > 600/mm3. A repeat eosinophil count will not be conducted in these patients.
- Patients with a recent history (i.e., six months or less) of myocardial infarction.
- Patients with unstable or life-threatening cardiac arrhythmias, including any patient with a newly diagnosed, clinically relevant arrhythmia on the ECG performed on visit 1. Patients with arrhythmias requiring an intervention (i.e. hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year should also be excluded from the study.
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- Patients who have been hospitalized for heart failure during the past three years.
- Patients with known active tuberculosis.
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
- Patients with a history of cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
- Patients with any respiratory infection in the 4 weeks prior to the screening visit and recovery within 6 weeks prior to visit 3 should be randomised 6 weeks following recovery from the infection or exacerbation.
- Patients who are currently in a pulmonary or cardiac rehabilitation program or who have completed a pulmonary or cardiac rehabilitation program in the last 6 months prior to the screening visit (visit 1).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
- Patients with symptomatic prostatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
- Patients with known narrow-angle glaucoma.
- Patients with a theophylline level > 5.0 μg/ml.
- Patients who are currently on β-blocker therapy including ocular preparations.
- Patients who are being treated with oral beta-adrenergics.
- Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions (See exclusion criterion No. 4).
- Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Patients who are being treated with monamine oxidase inhibitors or tricyclic antidepressants.
- Patients who have been treated with commercially available Spiriva® within the last 3 months prior to visit 1.
- Patients who are being treated with cromolyn sodium or nedocromil sodium within 1 month of visit 1.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e., oral contraceptives, intrauterine devices, diaphragm or subdermal implants e. g.: Norplant®).
- Significant alcohol or drug abuse within the past 5 years.
- Current participation in any other clinical trial or use of any investigational drug within one month or six half lives (whichever is greater) prior to screening visit (visit 1).
- Patients who use supplemental oxygen while at rest should be excluded.
- Patients with oxygen saturation below 85% during exercise despite supplemental oxygen therapy at visits 1 and 2 will be excluded from further participation.
- If in the investigator's opinion patients can only perform exercise testing with supplemental oxygen, supplemental oxygen therapy will be used at all following tests including rehabilitation program under constant level.
- Patients with a history of orthopedic, muscular or neurologic disease that would interfere with regular participation in aerobic exercise or with exercise testing.
- Patients with a body mass index > 30 kg/m2 or < 18 kg/m2.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled 7-week Trial to Investigate the Effects of Tiotropium Inhalation Capsules (18 μg) Once Daily on Exercise Tolerance, Daily Activity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 3 Weeks of Pulmonary Rehabilitation.
The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. The secondary objective of the study includes assessments of the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The third objective of the study is to investigate the correlation between the results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium Inhalation Capsule, Placebo Lactose Capsule
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Inhalation CapsuleDrug
Placebo Lactose CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Experimental | Not described Receives: Drug: Tiotropium Inhalation Capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Lactose Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 6 Minute Walking Distance (6MWD)
Measured: Baseline, day 51
Secondary outcomes (23)
Dyspnoea at the end of the 6MWT determined by the Modified Borg Scale (Dyspnoea Borg 6MWT),
Measured: Up to day 51
Endurance time during a constant work rate exercise test (CWR)
Measured: Up to day 51
Forced expiratory volume in one second (FEV1)
Measured: Up to day 51
Forced vital capacity (FVC)
Measured: Up to day 51
Slow vital capacity (SVC)
Measured: Up to day 51
Total lung capacity (TLC)
Measured: Up to day 51
COPD symptom scores (wheezing, shortness of breath, coughing, and tightness of chest)
Measured: Up to day 51
Transition Dyspnoea Indices (TDI)
Measured: Up to day 51
Change from baseline in Chronic Respiratory Questionnaire (CRQ),
Measured: Baseline, up to day 51
Change from baseline in patient's global evaluation on an 8-point-scale
Measured: Baseline, up to day 51
Amount of rescue medication used
Measured: Up to day 51
Daily physical activity, measured by a pedometer as number of registered activity impulses per day
Measured: Up to day 51
Total duration of endurance training on cycle ergometer during rehabilitation period
Measured: Up to day 51
Occurrence of adverse events
Measured: Up to day 51
Static Inspiratory capacity (IC)
Measured: Up to day 51
Residual volume (RV)
Measured: Up to day 51
Thoracic gas volume (TGV)
Measured: Up to day 51
Airways resistance (Raw)
Measured: Up to day 51
Change from baseline in blood pressure
Measured: Baseline, day 51
Change from baseline in pulse rate
Measured: Baseline, day 51
Change from baseline in laboratory tests
Measured: Baseline, day 51
Change from baseline in electrocardiogram (ECG)
Measured: Baseline, day 51
Change from baseline in physician's global evaluation on an 8-point-scale
Measured: Baseline, up to day 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2004
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172508
- Sponsor's protocol ID
- 205.289
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled 7-week Trial to Investigate the Effects of Tiotropium Inhalation Capsules (18 μg) Once Daily on Exercise Tolerance, Daily Activity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 3 Weeks of Pulmonary Rehabilitation.
- ClinicalTrials.gov ID
- NCT02172508
- Acronym / sponsor ID
- 205.289
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Mar 2004 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. The secondary objective of the study includes assessments of the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The third objective of the study is to investigate the correlation between the results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Experimental | Drug: Tiotropium Inhalation Capsule |
| Placebo | Placebo comparator | Drug: Placebo Lactose Capsule |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients must sign an Informed Consent Form consistent with ICH-GCP guidelines prior to participation in the trial, which might include pre-study washout of their usual pulmonary medications and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with an FEV1 ≤ 65% of predicted normal and FEV1 ≤ 70% of FVC on visit 1 and 3.
- Patients must show TGV ≥ 120% of predicted normal
- Male or female patients ≥ 40 but ≤ 75 years old
Key exclusion criteria (32 listed)
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinanalysis, if the abnormality defines a disease listed as an exclusion criterion.
- All patients with an serum glutamic-oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic-pyruvic transaminase (SGPT) > 80 IU/L, bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition.
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count > 600/mm3. A repeat eosinophil count will not be conducted in these patients.
- Patients with a recent history (i.e., six months or less) of myocardial infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium Inhalation Capsule | Drug | Tiotropium |
| Placebo Lactose Capsule | Drug | Placebo |
Primary outcome
Change from baseline in 6 Minute Walking Distance (6MWD)
Time frame: Baseline, day 51
23 secondary outcomes
Dyspnoea at the end of the 6MWT determined by the Modified Borg Scale (Dyspnoea Borg 6MWT),
Time frame: Up to day 51
Endurance time during a constant work rate exercise test (CWR)
Time frame: Up to day 51
Forced expiratory volume in one second (FEV1)
Time frame: Up to day 51
Forced vital capacity (FVC)
Time frame: Up to day 51
Slow vital capacity (SVC)
Time frame: Up to day 51
Total lung capacity (TLC)
Time frame: Up to day 51
COPD symptom scores (wheezing, shortness of breath, coughing, and tightness of chest)
Time frame: Up to day 51
Transition Dyspnoea Indices (TDI)
Time frame: Up to day 51
Change from baseline in Chronic Respiratory Questionnaire (CRQ),
Time frame: Baseline, up to day 51
Change from baseline in patient's global evaluation on an 8-point-scale
Time frame: Baseline, up to day 51
Amount of rescue medication used
Time frame: Up to day 51
Daily physical activity, measured by a pedometer as number of registered activity impulses per day
Time frame: Up to day 51
Total duration of endurance training on cycle ergometer during rehabilitation period
Time frame: Up to day 51
Occurrence of adverse events
Time frame: Up to day 51
Static Inspiratory capacity (IC)
Time frame: Up to day 51
Residual volume (RV)
Time frame: Up to day 51
Thoracic gas volume (TGV)
Time frame: Up to day 51
Airways resistance (Raw)
Time frame: Up to day 51
Change from baseline in blood pressure
Time frame: Baseline, day 51
Change from baseline in pulse rate
Time frame: Baseline, day 51
Change from baseline in laboratory tests
Time frame: Baseline, day 51
Change from baseline in electrocardiogram (ECG)
Time frame: Baseline, day 51
Change from baseline in physician's global evaluation on an 8-point-scale
Time frame: Baseline, up to day 51
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium Inhalation Capsule in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 6 Minute Walking Distance (6MWD) (time frame: Baseline, day 51). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.